Aerosol delivery system

ABSTRACT

A system for delivery of aerosol therapy to spontaneously breathing patients comprises a housing which defines a chamber. The housing has a base, a top and a main body extending between the base and the top. An ambient air inlet is located adjacent to the base and is normally closed by an inlet valve. The housing also has a patient port for receiving a mouthpiece or a face mask. The mouthpiece has an exhaust outlet closed by an exhaust valve. Similarly, the face mask has an exhaust outlet closed by an exhaust valve. Exhaled air is exhausted through the valves and to prevent recirculation through the chamber which would adversely affect dose efficiencies. The housing also has an aerosol port for receiving a vibrating mesh aerosol generating device. The aerosol port is located in a side of the main body of the housing for delivery of aerosol into the chamber between the inlet valve and the patient port. A boss extends upwardly from the base and is spaced-apart inwardly of the main body of the housing to define a reception space or well.

INTRODUCTION

This invention relates to the delivery of aerosol to patients inresponse to spontaneous breathing.

US2011/0108025 describes an aerosol transfer device coupled to anebuliser which generates an aerosol plume and to a patient interface.Upon inhalation by a patient ambient air is drawn into the device andflows counter-currently to the aerosol plume. However, the device isrelatively large and cumbersome for use and complex to manufacture. Itis also restricted to particular uses

STATEMENTS OF INVENTION

According to the invention there is provided an aerosol delivery devicecomprising a housing defining a chamber, the housing having:—

-   -   a base;    -   a top;    -   a main body extending between the base and the top;    -   an air inlet closed by an inlet valve, the air inlet being        located adjacent to the base of the housing;    -   a patient port for receiving a mouthpiece or a face mask, the        mouthpiece or face mask having an exhaust outlet closed by an        exhaust valve; and    -   an aerosol port for receiving a vibrating mesh aerosol        generating device, the aerosol port being located in a side of        the main body of the housing for delivery of aerosol into the        chamber between the inlet valve and the patient port,    -   the inlet valve being breath actuatable for movement between an        inspiration configuration in which the inlet valve is open and        an exhalation configuration in which the inlet valve is closed.

In one embodiment the housing comprises a boss extending from the baseof the housing and being spaced-apart inwardly of the main body of thehousing to define a reception space.

In one case the inlet valve is mounted to the boss for movement betweenthe open and closed configurations. The boss may comprise a raisedregion against which a portion of the inlet valve is seated. The raisedregion may be defined by a rim which extends at least partially aroundthe boss.

In one embodiment the housing comprises an oxygen supply port forconnection to a supply of oxygen. The oxygen supply port may be normallyclosed by the inlet valve. In one case the oxygen supply port is locatedwithin the margins of the boss.

In one embodiment a longitudinal axis through a center of the aerosolinlet port is substantially at right angles with respect to alongitudinal axis through the main body of the housing.

In one case a longitudinal axis through a center of the patient port isoffset from a longitudinal axis through a center of the inlet. The mainbody of the housing may comprise a tapered transition section to thepatient port.

The invention also provides an aerosol delivery system comprising anaerosol deliver device of the invention and a mouth piece or a face maskfor connection to the patient port.

In a preferred embodiment the mouthpiece or face mask comprises anexhaust outlet closed by an exhaust valve, the inlet and exhaust valvesbeing breath actuated from an inspiration configuration in which theinlet valve is open and the exhaust valve is closed to an exhalationconfiguration in which the inlet valve is closed and the exhaust valveis open.

In one case a longitudinal axis through a center of the patient port ofthe mouth piece subtends on angle of from 0° to 90° with a longitudinalaxis of the main body of the housing. The angle may be approximately60°.

In a further aspect the invention provides an aerosol delivery systemfurther comprising a vibrating mesh aerosol generator for connection tothe aerosol port for delivery of aerosol into inspiration gas flowingthrough the chamber when then inlet valve is open.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be more clearly understood from the followingdescription thereof, given by way of example in which:

FIG. 1 is an isometric, partially cut-away view of an aerosol deliverysystem according to the invention;

FIG. 2 is an isometric view of an aerosol delivery device of theinvention forming part of the system of FIG. 1;

FIGS. 3 and 4 are cross sectional views of the aerosol delivery systemof FIG. 1;

FIG. 5 is an isometric view of an air inlet end of the device with avalve removed;

FIGS. 6 and 7 are cross sectional views of the air inlet end of FIG. 5;

FIG. 8 is an isometric view of the air inlet end of the device with avalve in situ;

FIGS. 9 to 10 are elevational and cross sectional views of the air inletend of FIG. 8; and

FIGS. 11 to 13 are isometric views of the device and an associated facemask.

DETAILED DESCRIPTION

The invention provides a system for delivery of aerosol therapy tospontaneously breathing patients.

Referring to the drawings there is illustrated an aerosol deliverydevice according to the invention which comprises a housing 1 whichdefines a chamber 2. The housing has a base 3, a top 4 and a main body 5extending between the base 3 and the top 4. An ambient air inlet 6 islocated adjacent to the base 3 and is normally closed by an inlet valve7.

The housing also has a patient port 10 for receiving a mouthpiece 11 ora face mask 12. The mouthpiece 11 has an exhaust outlet 14 closed by anexhaust valve 15. Similarly, the face mask 12 has an exhaust outletclosed by an exhaust valve 16. Exhaled air is exhausted through thevalves 15 and 16 to prevent recirculation through the chamber 2 whichwould adversely affect dose efficiencies.

The housing also has an aerosol port 20 for receiving a vibrating meshaerosol generating device 25. The aerosol port 20 is located in a sideof the main body of the housing 1 for delivery of aerosol into thechamber 2 between the inlet valve 7 and the patient port 10, generallyperpendicular to the flow of air through the chamber 2.

The inlet valve 7 and the exhaust valves 15, 16 are one-way breathactuated and move from an inspiration configuration in which the inletvalve 7 is open and the exhaust valve 15,16 is closed to an exhalationconfiguration in which the inlet valve 7 is closed and the exhaust valve15,16 is open.

The housing 1 comprises a boss 30 extending upwardly from the base 3.The boss is spaced-apart inwardly of the main body 5 of the housing 1 todefine a reception space or well 31. This facilitates collection of anyrain-out within the chamber 2. The inlet valve 7 is of a flexiblepolymeric material such as Elastosil R401-40 (Wacker, Munich, Germany)and has a receiver for mounting to a mounting element 33. The valve 7 ismovable relative to the boss 30 between the open and closedconfiguration. The boss 30 also has a raised region which in this caseis defined by a rim 35 which extends around the boss 30 to lift onesection of the valve 7. This assists in preventing adhesion between thevalve 7 and the boss 30 and facilitates opening of the valve even if theinhalation force applied is low.

The housing 2 also has an oxygen supply port 40 for connection to asupply of supplemental oxygen. In this case the oxygen supply port 40 islocated in the base 3 of the device within the margins of the boss 30and is normally closed by the inlet valve 7. Thus, the inlet valveoccludes the oxygen port when no oxygen flow is connected, thusmaximising device efficiency. When an oxygen supply is connected thevalve 7 opens. This arrangement avoids the necessity for a separates capor valve on the oxygen supply port and diffuses oxygen flow entering thechamber 2 which improves the efficiency of the device.

It will be noted that a longitudinal axis through a center of theaerosol delivery port 20 is substantially at right angles with respectto a longitudinal axis through the main body of the housing 1. Thisfeature assists in reducing aerosol impaction and therefore maximisesdose efficiency during changes in flow direction associated withinhalation and exhalation. It also facilitates nebuliser placement forcable management and device usability.

A longitudinal axis through a center of the patient port 10 is offsetfrom a longitudinal axis through a center of the air inlet. This featurealso assists in reducing aerosol impaction and therefore maximises doseefficiency. This optimium placement also minimises device size andtherefore maximises usability.

The main body of the housing 1 comprises a tapered transition section 50to the patient port 10. This provides minimum resistance to flow andminimises rain-out whilst maximising efficiency.

Referring in particular to FIG. 4, it will also be noted that alongitudinal axis through a center of the patient port of the mouthpiece subtends an angle α of from about 0° to about 90°, in this caseapproximately 60° to the main body of the housing. This also maximisesdose efficiency. Referring in particular to FIG. 4 the dimensions a to hare important in optimising device efficiency. The approximate valuesfor these dimensions are as follows.

-   -   a: range 40-60 optimum approximately 46 mm    -   b: range 22-66 optimum approximately 39 mm    -   c: range 25-45 optimum approximately 37 mm    -   d: range 0-10 optimum approximately 9 mm    -   e: range 50-90 optimum approximately 67 mm    -   f: range 17-25 optimum approximately 17 mm    -   g: range 70-90 optimum approximately 70 mm    -   h: range 20-30 optimum approximately 24 mm

In the invention high efficiency is achieved by:

-   -   Chamber design (i.e. diameter, length, etc.)    -   Neb positioning (i.e. perpendicular to chamber main axis,        distance between neb and opposing wall and distance between neb        and inlet valve)    -   Valves configuration to control the flow of air through the        device    -   Angle of mouthpiece to chamber    -   Alignment of chamber outlet with bottom wall    -   Use of inlet valve to diffuse flow oxygen into the device

Rainout management is achieved by:

-   -   Inlet valve is located in a raised position ensure it does not        contact rainout    -   Inlet valve seals on raised rim to reduce adhesion due to        rainout    -   Inlet valve seal design to lift one section of valve to reduce        the pressure differential required to open valve

The system can be used with or without supplementary oxygen.

The aerosol generator 25 is a vibrating mesh type nebuliser as describedin our WO2012/046220A, the entire contents of which are incorporatedherein by reference.

Aerosol generators comprising a vibratable member and a plate bodyoperably coupled to the vibratable member are known, the plate body hasa top surface, a bottom surface, and a plurality of apertures extendingfrom the top surface to the bottom surface. The apertures may be taperedsuch that when a liquid is supplied to one surface and the apertureplate is vibrated using the vibratable member, liquid droplets areejected from the opposite surface. Details of such known systems aredescribed for example in U.S. Pat. No. 6,235,177, US2007/0023547A, andU.S. Pat. No. 7,066,398, the entire contents of which are hereinincorporated by reference.

The invention may be used to provide treatments for a variety ofaliments using a variety of aerosolisable medicaments. The ailments mayinclude pulmonary ailments such as ventilator-associated pneumonia,hospital-acquired pneumonia, community-acquired pneumonia, asthma,cystic fibrosis, mycobacterial infection, mucociliary clearanceconditions, bronchitis, staph infection, fungal infections, viralinfections, tuberculosis, protozoal infections, emphysema, hereditaryemphysema, Chronic Obstructive Pulmonary Disease (COPD) and acuteexacerbation of COPD, among others. The aerosolizable medicaments usedto treat the ailments may include antitrypsins (such as alpha-1antitrypsin), antibiotics, anti-infectives, antivirals, anti-oxidants,epithelium sodium channel blockers, bronchodilators, beta-antagonists(short and long acting) corticosteroids, leukotrienes, proteaseinhibitors, surfactants, and vaccines, among other medicaments. Theailments may further include non-pulmonary-related, such as systemicconditions, such as diabetes, cancer, immune diseases, cardiovascularconditions, metabolic diseases and the like.

The invention may be used in a method of treating a patient byadministering to the patient any desirable nebulised dose of aerosol.

In some cases the method of treating a patient involves administering tothe patient a discrete nebulised dose of aerosol comprising from 0.05 mLto about 50 mL of a medicament or greater than 50 mL when administeringcontinuous aerosol therapy.

Also provided are methods of treatment by administering to a patient anaerosolised formulation comprising an anti-infective dissolved in anaqueous solution that is adjusted to a pH between about 3.0 and 10.5.

In some cases the medicament is administered continuously.

In other cases the medicament is administered intermittently.

The systems are configurable to administer aerosolised medicament, suchas an anti-infective, to a spontaneous-breathing patient.

Substantially all of the device may be reused for multiple treatmentswith a single patient before disposing thereof.

The device may be used for only a single patient, then disposed.

A filter can be positioned at the exhaust outlet to capture exhausteddrug.

The invention is not limited to the embodiments hereinbefore described,which may be varied in construction and detail.

1-15. (canceled)
 16. An aerosol delivery device, comprising: a bodydefining a chamber and having a first end and a second end and alongitudinal axis; an aerosol port in fluid communication with thechamber and positioned axially closer to the first end than the secondend of the body; a boss coupled to the first end and received within thechamber; an inlet valve coupled to the boss and positioned within thechamber; and a patient interface coupled to the second end.
 17. Theaerosol delivery device of claim 16, wherein the inlet valve isbreath-actuatable.
 18. The aerosol delivery device of claim 16, whereinthe boss includes an air inlet port and an oxygen supply port.
 19. Theaerosol delivery device of claim 18, wherein the oxygen supply port isparallel to the air inlet port.
 20. The aerosol delivery device of claim16, wherein a diameter of the second end is smaller than a diameter ofthe first end of the body.
 21. The aerosol delivery device of claim 16,wherein a central longitudinal axis of the aerosol port is perpendicularto a central longitudinal axis of the chamber.
 22. The aerosol deliverydevice of claim 16, wherein the patient interface includes an exhaustvalve.
 23. The aerosol delivery device of claim 16, wherein the secondend is received within the patient interface.
 24. An aerosol deliverydevice, comprising: a body defining a chamber and having a first end anda second end; an aerosol port in fluid communication with the chamberand positioned axially between the first end and the second end of thebody; a boss coupled to the first end and received within the chamber;an inlet valve coupled to the boss and positioned within the chamber;and a patient interface coupled to the second end; wherein a centrallongitudinal axis of the first end is parallel to a central longitudinalaxis of the second end.
 25. The aerosol delivery device of claim 24,wherein a central longitudinal axis of the patient interface is angledwith respect to the central longitudinal axis of the second end.
 26. Theaerosol delivery device of claim 24, wherein an angle between thecentral longitudinal axis of the patient interface and the centrallongitudinal axis of the second end is about 60°.
 27. The aerosoldelivery device of claim 24, wherein the patient interface includes anexhaust valve.
 28. The aerosol delivery device of claim 24, wherein adiameter of the second end is smaller than a diameter of the first endof the body.
 29. The aerosol delivery device of claim 24, wherein thesecond end is received within the patient interface.
 30. The aerosoldelivery device of claim 24, wherein the boss has a length terminatingwithin the chamber upstream of the aerosol port.
 31. The aerosoldelivery device of claim 24, wherein the boss includes an air inlet portand an oxygen supply port.
 32. The aerosol delivery device of claim 31,wherein the oxygen supply port includes a central longitudinal axisoffset with respect to a central longitudinal axis of the boss.
 33. Anaerosol delivery device, comprising: a body defining a chamber andhaving a first end and a second end; an aerosol port in fluidcommunication with the chamber and positioned axially between the firstend and the second end of the body; a base, wherein the first end isreceived within the base; a boss extending from the base and receivedwithin the chamber; a reception space located radially between the bossand the body; an inlet valve coupled to the boss and positioned withinthe chamber; and a patient interface coupled to the second end.
 34. Theaerosol delivery device of claim 33, wherein the boss includes an airinlet port and an oxygen supply port, wherein the oxygen supply portincludes a central longitudinal axis offset with respect to a centrallongitudinal axis of the boss.
 35. The aerosol delivery device of claim33, wherein a diameter of the second end is smaller than a diameter ofthe first end of the body.
 36. The aerosol delivery device of claim 33,wherein the second end is received within the patient interface.